Actively Recruiting
Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis
Led by Odense University Hospital · Updated on 2023-11-07
340
Participants Needed
1
Research Sites
378 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis to either vacuum assisted closure or relaparotomy "on-demand".
CONDITIONS
Official Title
Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older scheduled for acute laparotomy due to suspected peritonitis from small bowel, colon, or rectum perforation
- Confirmed purulent, enteric, or fecal contamination in at least 2 out of 4 abdominal quadrants
You will not qualify if you...
- Diffuse peritonitis from sources other than small intestine, colon, or rectum
- Peritonitis from stomach, duodenum, gallbladder, appendix, necrotizing pancreatitis, salpingitis, or peritoneal dialysis
- Primary peritonitis
- Immunocompromised state (ongoing chemotherapy or prednisolone >20 mg/day)
- Chronic liver disease
- Pregnancy
- End-stage disease
- Laparoscopic surgery not converted to laparotomy
- Acute superior mesenteric artery occlusion
- Peritoneal carcinomatosis
- Abdominal trauma
- Lack of surgical equipoise consent
- Peritonitis confined to only 1 abdominal quadrant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Odense University Hospital
Odense, Fyn, Denmark, 5000
Actively Recruiting
Research Team
P
Pooya Rajabaleyan, M.D.
CONTACT
M
Mark Ellebæk, M.D., Ph.d.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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